BAROSTIM THERAPY Improves Cardiac RemoDeling in Heart Failure - BiRD HF

CVRx Incorporated0 个研究点目标入组 110 人开始时间: 2017年11月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•To be eligible for this study:
•1. Signed Ethics Committee (EC) approved informed consent form.
•2. Implanted with a de novo BAROSTIM NEO System within 30 days prior to consent, and implant met the CE-Mark approved indications and contraindications for BAROSTIM NEO in the treatment of heart failure:
•Indication: New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) = 35% despite being treated with the appropriate heart failure guideline directed therapy.
•Contraindications for the implantation of the BAROSTIM NEO
•o Bilateral carotid bifurcations located above the level of the mandible
•o Baroreflex failure or autonomic neuropathy
•o Uncontrolled, symptomatic cardiac bradyarrhythmias
•o Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
•o Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
•3. BAROSTIM THERAPY has not yet been activated.
•4. Age at least 21 years at the time of consent.

•If any of the following criteria are met, subjects are not eligible for this study.
•1. Received cardiac resynchronization therapy (CRT) within six months of activation, or is actively receiving CRT.
•2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to ESC guidelines for the treatment of congestive heart failure.

发起方

CVRx Incorporated